Prior and Current Procedures
Subject 40912 had a previous peripheral artery bypass surgery that took place on 2005-12-16 because a lesion was identified in the left femoral-popliteal artery. The lesion was deemed severe and extensive and the subject was not a good candidate for percutaneous vascular intervention (PVI), hence a bypass graft surgery was performed. Note PRCAT is populated with Prior Intervention. This information is collected during the SCREEN visit on 2007-01-01 (PRDTC).
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRREFID | PRSEQ | PRTRT | PRLOC | PRLAT | PRCAT | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
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| 1 | TUDY01 | PR | 40912 | graft01 | 1 |
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CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERYPeripheral Artery Bypass Graft | Femoral-popliteal Artery | Left | Prior Intervention | 1 | SCREEN | 2007-01-01 | 2005-12-16T06:00 | 2005-12-16T09:00 |
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The findings about procedure dataset below shows several important parameters from the Prior Peripheral Artery Bypass Surgery:
- The native vessel on which the bypass graft was built - row 1.
- The type of the bypass graft (e.g. arterial, venous, synthetic, cadaveric) - row 2
- The locations where the two ends of the bypass vessel graft connect with the native vessel - rows 3-4.
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| Rowcaps |
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| Row 1: | Shows the graft vessel was built on the |
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LEFT FEMORO-POPLITEAL ARTERY| Left Femoral-popliteal Artery. | | Row 2: | Shows the bypass graft type was venous cadaveric graft, which is composed of a |
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artery | vein harvested from a cadaver. | | Rows 3-4: | Show the graft anastomoses (connections) to the |
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LEFT FEMORO-POPLITEAL ARTERY | Left Femoral-popliteal Artery were on the |
LEFT COMMON FEMORAL ARTERY and LEFT POPLITEAL ARTERY| Left Common femoral Artery and Left Popliteal Artery. |
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Row | STUDYID | DOMAIN | USUBJID | FAREFID | FASEQ | FATEST | FAOBJ | FACAT | FAORRES | VISITNUM | VISIT | TUDTC |
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| 12 | TUDY01 | FA | 40912 | 1 | Graft Construction Location | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | LEFT FEMORO-POPLITEAL ARTERY | 1 | SCREEN | 2007-01-01graft01 | 2 | TUDY01 | FA | 40912 | 2 | Bypass Graft Type | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | Peripheral Artery Bypass Graft | Prior Intervention | Cadaveric Graft, VenousCADAVERIC GRAFT, VENOUS | 1 | SCREEN | 2007-01-01 |
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| 3 | TUDY01 | FA | 40912 | graft01 | 3 | Proximal Graft Anastomosis (connection) Location | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | Peripheral Artery Bypass Graft | Prior Intervention | Common femoral ArteryLEFT COMMON FEMORAL ARTERY | 1 | SCREEN | 2007-01-01 |
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| 4 | TUDY01 | FA | 40912 | graft01 | 4 | Distal Graft Anastomosis (connection) Location | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | Peripheral Artery Bypass Graft | Prior Intervention | Popliteal ArteryLEFT POPLITEAL ARTERY | 1 | SCREEN | 2007-01-01 |
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On 2007-0201-01, during the Peripheral Vascular Intervention (PVI) procedure 03, the subject had undergone lower-extremity CT peripheral angiography during which time two separate lesions were located in the left leg of the subject. One lesion (Lesion lesion 1) lesion was in the native FEMORO-POPLITEAL PERIPHERAL ARTERY, the other (lesion 2) in the FEMORO-POPLITEAL graft. While Lesion 1 is considered as non-target, lesion 2 is considered as target. A stent was implant into the to correct the stenosis caused by the lesion. Two separate lesions are located in the left leg of the subject, one (Lesion 1) in the native FEMORO-POPLITEAL PERIPHERAL ARTERY, the other (lesion 2) in the FEMORO-POPLITEAL graft. left femoral-popliteal artery (this was the lesion that led to the graft bypass surgery back in 2005) the other lesion (graft lesion 1) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, graft lesion 2 1 is considered as target .for the subsequent PVI treatment. On 2007-01-05, a stent was implanted into the left femoral-popliteal graft to correct the stenosis caused by the lesion (graft lesion 1). Note this information is collected on 2007-02-07 during VISIT 1.
Below procedure data show cardiac catheterization and stent implantation.
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| Rowcaps |
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| Row 1: | Shows one or more lesions have been identified in the lower limb region. |
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| Row 2: | shows the native vessel that contains a lesion is the left femoro-popliteal peripheral artery. |
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| Row 3: | Shows the lesion is found in the left popliteal artery above the knee. |
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| Row 4: | Shows the graft vessel that contains a lesion is the femoro-popliteal graft. |
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| Row 5: | Shows the lesion is located in the proximal anastomosis (connection) of the graft. |
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| Row 6: | Shows the limb that contains lesion is the left leg. |
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| Row 7: | Shows the lesion in the native vessel is considered as non-target. In the context of clinical investigation, any vessel or bypass graft not treated or for which treatment was not attempted with a device or technique being studied. This includes vessels treated with (nonstudy) vascular intervention and vessels managed medically. (ACC/AHA Clinical Data Standards 2014) |
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| Row 8: | Shows the lesion is considered as non-target. In the context of clinical investigation, any lesion not treated or for which treatment was not attempted with the device or technique being studied. This includes lesions treated with (nonstudy) PVI and lesions managed medically. (ACC/AHA Clinical Data Standards 2014) |
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| Row 9: | Shows the graft vessel is considered as target. In the context of clinical investigation, a target vessel is any noncardiac or nonintracranial blood vessel that contains the target lesion treated with the study device. |
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| Row 10: | Shows the lesion in the graft vessel is considered target. In the context of clinical investigation, any lesion treated or for which treatment was attempted with a device or technique being studied. (ACC/AHA Clinical Data Standards 2014) |
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| Row 11: | Shows the left leg is considered as target. The target limb is the extremity that contains the target lesion and all the native vessels upstream and downstream from it, including side branches. (Jordan: this data element is really terrible, because a graft lesion can be a target lesion if deemed treatable by PVI, so the limb that contains a graft lesion would also be considered as a target limb. I hate common data elements, i think this test should just be removed from the dataset because the original source is really terrible.) |
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| Dataset2 |
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TUSEQTULNKIDTUTESTTULOCTULATTULOCDTLTUORRES| TUSTRESC | TURESLOC
| TURESLAT | TURLOCDL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC | TULesion Indicator | LOWER LIMB REGION | Y | Y | | CT PERIPHERAL ANGIOGRAPHY |
INVESTIGATOR| DIAGNOSTIC | LOWER EXTREMITIES | 2 |
BASELINE012 | TUDY01 | TU | 40912 | 2 | Vessel 1-Lesion 1 | Native Vessel with Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | | 07 | 2007-01-03T08:00 | 2007-01-03T09:00 |
| TUDY01 | PR | 40912 | 2 | CT PERIPHERAL ANGIOGRAPHY | PVI |
| 2 | VISIT 1 |
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3 | TUDY01 | TU | 40912 | 3 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE014 | TUDY01 | TU | 40912 | 4 | Graft Vessel 1-Lesion 2 | Graft Vessel with Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | LEFT FEMORO-POPLITEAL GRAFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | 5 | TUDY01 | TU | 40912 | 5 | Lesion 2 | Graft Lesion Location Identification | LEFT FEMORO-POPLITEAL GRAFT | LOCATED | LOCATED | GRAFT ANASTOMOSIS PROXIMAL | 5MM FROM THE ORIGIN OF THE GRAFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | | 07 | 2007-01-05T07:00 | 2007-01-05T09:00 | | 2 | TUDY01 | PR | 40912 | 3 | Cardiac Catheterization | PVI |
| 2 | VISIT 1 |
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BASELINE016 | TUDY01 | TU | 40912 | 6 | Limb 1 | Limb with Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | LEG | LEFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | 7 | TUDY01 | TU | 40912 | 7 | Vessel 1-Lesion 1 | Native Vessel with Lesion Role Identification | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT | NON-TARGET | NON-TARGET | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | 8 | TUDY01 | TU | 40912 | 8 | Lesion 1 | Lesion Role Identification | POPLITEAL ARTERY | LEFT | ABOVE KNEE | NON-TARGET | NON-TARGET | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | 9 | TUDY01 | TU | 40912 | 9 | Graft Vessel 1-Lesion 2 | Graft Vessel with Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | LEFT | TARGET | TARGET | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | 10 | TUDY01 | TU | 40912 | 10 | Lesion 2 | Graft Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | GRAFT ANASTOMOSIS PROXIMAL | TARGET | TARGET | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | 11 | TUDY01 | TU | 40912 | 11 | Limb 1 | Limb with Lesion Role Identification | LEG | LEFT | TARGET | TARGET | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | |
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The subject had undergone a PVI
| 07 | 2007-01-05T07:00 | 2007-01-05T09:00 | | 3 | TUDY01 | PR | 40912 | 4 | Stent Implantation | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
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Lesion Type and Location Identification
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| title | Peripheral Artery Lesion CRF |
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| CDASH for Peripheral Arterial Lesion |
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| CDASH for Peripheral Arterial Lesion |
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The below data show lesion location identification from the diagnostic CT peripheral angiography procedureNote these parameters have been mapped to TR in the published CV-endpoint TAUG, but i think they are "disease response to treatment" type of data. Whether the lesion or the affected vessel have failed (or using tumor RS terminology, did not responded to) percutaneous vascular intervention treatment has very specific definition by published criteria.
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| Row 1: | The target lesion in the graft did not fail according to XXXXShows one or more lesions have been identified in the lower limb region. |
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| Row 2: | The target graft vessel did not fail according to XXXShows lesion 1 is identified in the left popliteal artery above the knee. |
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| Row 3: | The target graft vessel is patent according to XXX. |
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| Row 4: | The target limb did not fail according to XXXX. |
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| Shows graft lesion 1 is located in the femoro-popliteal artery graft. Note the use of the NSV --RLGFFG, Result Location is Graft Flag. Note I did map PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT to TU result LOCDTL because this variable is not controlled and the flag indicates that we are dealing with a graft location. |
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| hi1style | #e3fcef |
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| hi1 | TRLOC |
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| tableid | TR1 |
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| TRSEQTRGRPIDTRLNKIDTRTESTTRORRESTRSTRESCTRMETHODVISITNUMVISITCVDTC1TUDY01TR409121TARGET| Lesion 2 | Lesion Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY | 2 | BASELINE | 2007-02-01 | 3 | TUDY01 | TR3TARGETGraft Vessel 1- 2Vessel Failure N | N | PERIPHERAL ANGIOGRAPHY | 2 | BASELINE | 2007-02-01 | 4 | TUDY01 | TR | 40912 | 4 | TARGET | Graft Vessel 1-Lesion 2 | Vessel Patency Indicator | | LOWER LIMB REGION | Y | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 |
BASELINE015TR5TARGET | Limb 1-Lesion 2 | Limb Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY | 2 | BASELINE | 2007-02-01 | |
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I think this should be modeled in RS in the following fashion, similar to that of Tumor response to treatment modeling in RS.
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| Lesion 1 | ABNEXAM | Examination for Abnormality | LOWER LIMB REGION | LESION | LESION | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| | 3 | TUDY01 | TU | 40912 | 3 | graft01 | Graft Lesion 1 | ABNEXAM | Examination for Abnormality | LOWER LIMB REGION | LESION | LESION | FEMORO-POPLITEAL ARTERY | LEFT | PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| Variable | Label | Type | Role | Origin |
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| TURLGFFL | Result location is Graft Flag | text | Non-Standard Record Qualifier | CRF |
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Row
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STUDYID
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DOMAIN
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USUBJID
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RSLNKID
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RSTEST
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RSSTRESC
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VISITNUM
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VISIT
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CVDTC
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TUDY01
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TUDY01
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TUDY01
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Vessel Patency Indicator
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TUDY01
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